CAMLOCOR 16 mg/10 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Camlocor, 8 mg+5 mg, tablets
3. Camlocor, 16 mg+5 mg, tablets
4. Camlocor, 16 mg+10 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Camlocor and what is it used for
6. Important information before taking Camlocor
   1. When not to take Camlocor
   2. Warnings and precautions
   3. Children and adolescents
   4. Camlocor and other medicines
   5. Camlocor with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Camlocor contains lactose and sodium
7. How to take Camlocor
   1. Taking a higher dose of Camlocor than recommended
   2. Missing a dose of Camlocor
   3. Stopping Camlocor treatment
8. Possible side effects
   1. Reporting side effects
9. How to store Camlocor
10. Package contents and other information
    1. What Camlocor contains
    2. What Camlocor looks like and contents of the pack
    3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: patient information

Camlocor, 8 mg+5 mg, tablets

Camlocor, 16 mg+5 mg, tablets

Camlocor, 16 mg+10 mg, tablets

candesartan cilexetil + amlodipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Camlocor and what is it used for
• 2. Important information before taking Camlocor
• 3. How to take Camlocor
• 4. Possible side effects
• 5. How to store Camlocor
• 6. Package contents and other information

1. What is Camlocor and what is it used for

Camlocor contains two active substances: candesartan cilexetil and amlodipine. Both of these substances help lower high blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists.
• Amlodipine belongs to a group of medicines called calcium channel blockers.

Both substances prevent blood vessels from narrowing, causing them to widen, resulting in lowered blood pressure. Camlocor is used to treat high blood pressure (hypertension) in adult patients who have already taken candesartan cilexetil and amlodipine in the same doses as in Camlocor, instead of taking the two medicines separately.

2. Important information before taking Camlocor

When not to take Camlocor

• after the third month of pregnancy (it is also recommended to avoid taking Camlocor in early pregnancy - see section "Pregnancy and breastfeeding");
• in children under 1 year of age;

In case of doubt about any of the above conditions, the patient should consult their doctor or pharmacist before taking Camlocor.

Warnings and precautions

Before starting to take Camlocor, the patient should discuss it with their doctor or pharmacist. The patient should inform their doctor if they have or have had any of the following disorders or conditions:

• heart, liver, or kidney disease, or dialysis treatment;
• a recent kidney transplant;
• severe vomiting or diarrhea;
• a disease of the adrenal glands called Conn's syndrome (primary hyperaldosteronism);
• low blood pressure;
• a recent stroke;
• the patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy - it is not recommended to take Camlocor in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see section "Pregnancy and breastfeeding");
• a recent heart attack;
• heart failure;
• significant increase in blood pressure (hypertensive crisis);
• the need to increase the dose in elderly patients.

Before taking Camlocor, the patient should talk to their doctor if they are taking:

• digoxin,
• any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme (ACE) inhibitor, such as enalapril, lisinopril, ramipril, especially if the patient has kidney problems related to diabetes;
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the section "When not to take Camlocor".

If the patient is scheduled for surgery, they should inform their doctor or dentist about taking Camlocor. This is because Camlocor, in combination with certain anesthetics, may cause a decrease in blood pressure.

Children and adolescents

Camlocor is not recommended for children and adolescents under 18 years of age.

Camlocor and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. Camlocor may affect the action of other medicines, and other medicines may affect Camlocor. If the patient is taking certain medicines, their doctor may periodically recommend blood tests. In particular, the patient should inform their doctor about taking any of the following medicines. The doctor may recommend a dose change and/or take other precautions:

• other blood pressure-lowering medicines, including beta-blockers, diazoxide, and ACE inhibitors, such as enalapril, captopril, lisinopril, or ramipril;
• non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines that relieve pain and inflammation);
• acetylsalicylic acid (in a dose greater than 3 g per day), taken to relieve pain and inflammation;
• potassium supplements or salt substitutes containing potassium (medicines that increase potassium levels in the blood);
• heparin (a blood thinner);
• diuretics;
• lithium (a medicine used to treat mental disorders);
• ACE inhibitor or aliskiren (see also sections "When not to take Camlocor" and "Warnings and precautions");
• ketokonazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV);
• rifampicin, erythromycin, clarithromycin (used to treat bacterial infections);
• St. John's Wort (Hypericum perforatum);
• verapamil, diltiazem (used to treat heart conditions);
• dantrolene (used in severe body temperature disorders);
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that affect the immune system);
• simvastatin (a medicine that lowers cholesterol levels);
• cyclosporine (an immunosuppressive medicine).

Camlocor may lower blood pressure more, if the patient is taking other blood pressure-lowering medicines.

Camlocor with food and drink

While taking Camlocor, the patient should not drink grapefruit juice or eat grapefruits, as they may increase the levels of the active substance amlodipine in the blood, which may result in unpredictable intensification of the blood pressure-lowering effect of Camlocor. While taking Camlocor, the patient should talk to their doctor before drinking alcohol. Camlocor may cause dizziness or fainting.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Pregnancy The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Camlocor before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Camlocor. It is not recommended to take Camlocor in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus. Breastfeeding The patient should inform their doctor about breastfeeding or intending to breastfeed. It is not recommended to take Camlocor during breastfeeding, especially when breastfeeding a newborn or premature baby. The doctor may recommend taking another medicine. It has been shown that small amounts of amlodipine pass into breast milk.

Driving and using machines

Camlocor may affect the ability to drive and use machines. If the medicine causes nausea, dizziness, fatigue, or headache, the patient should not drive or operate machinery - they should contact their doctor immediately.

Camlocor contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Camlocor

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose of Camlocor is one tablet per day. The tablet should be swallowed with a glass of water, during or outside of meals. It is recommended to take the medicine every day at the same time. The patient should not take Camlocor with grapefruit juice. It is important to continue taking Camlocor as long as the doctor recommends.

Taking a higher dose of Camlocor than recommended

Taking too many tablets may cause a significant decrease in blood pressure. The patient may experience dizziness, a feeling of "emptiness" in the head, fainting, or weakness. In case of a very significant decrease in blood pressure, shock may occur. The skin may become cool and moist, and the patient may lose consciousness. Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur. If the patient has taken too many Camlocor tablets, they should contact their doctor or go to the emergency department of the nearest hospital immediately.

Missing a dose of Camlocor

The patient should not worry. If they forget to take a tablet, they should skip it. The next dose should be taken at the right time. The patient should not take a double dose to make up for the missed dose.

Stopping Camlocor treatment

The doctor will inform the patient about the duration of treatment. If the patient stops taking Camlocor before the doctor recommends it, the disease may recur. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Camlocor can cause side effects, although not everybody gets them. If the patient experiences any of the following side effects, they should contact their doctor immediately:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and/or throat, causing severe difficulty in breathing;
• severe skin reactions, including intense rash, hives, redness of the skin, severe itching, blistering, and peeling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, arrhythmia;
• pancreatitis, which may cause severe abdominal pain, radiating to the back, with very poor general condition.

Candesartan, a component of Camlocor, may cause a decrease in the number of white blood cells. This may lead to decreased immunity to infections, so the patient may experience fatigue, infection, and fever. If such symptoms occur, the patient should contact their doctor. The doctor may periodically recommend blood tests to check if Camlocor is causing blood disorders (agranulocytosis). Possible side effects associated with taking candesartan Frequently (may occur in less than 1 in 10 patients):

• Dizziness/vertigo
• Headache
• Respiratory tract infection
• Low blood pressure, which may cause fainting or dizziness
• Changes in blood test results:
• increased potassium levels in the blood, especially in patients with kidney problems or heart failure; in case of significant increase, fatigue, weakness, irregular heartbeat, or tingling may occur
• effect on kidney function, especially in patients with kidney problems or heart failure; in very rare cases, kidney failure may occur

Very rarely (may occur in less than 1 in 10,000 patients):

• Swelling of the face, lips, tongue, and/or throat
• Decreased number of red or white blood cells - may cause fatigue, infection, or fever
• Skin rash, hives
• Itching
• Back pain, joint or muscle pain
• Liver function disorders, including hepatitis - may cause fatigue, yellowing of the skin and eyes, and flu-like symptoms
• Cough
• Nausea
• Changes in blood test results:
• decreased sodium levels in the blood; in case of significant decrease, weakness, lack of energy, or muscle cramps may occur

Unknown (frequency cannot be estimated from the available data):

• Diarrhea

Possible side effects associated with taking amlodipine Very common (may occur in at least 1 in 10 people):

• Edema (fluid retention in the body)

Common (may occur in less than 1 in 10 patients):

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Palpitations (awareness of heart function), sudden reddening, especially of the face and neck
• Abdominal pain, nausea
• Change in bowel movements, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankle area

Other side effects that have been reported are listed below. If any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Uncommon (may occur in less than 1 in 100 patients):

• Mood changes, anxiety, depression, insomnia
• Tremor, taste disorders, fainting
• Numbness or tingling of limbs, lack of sensation
• Tinnitus
• Low blood pressure
• Sneezing/ runny nose due to nasal mucosa inflammation (rhinitis)
• Cough
• Dryness of the mucous membranes of the mouth, vomiting
• Hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration
• Urination disorders, increased need to urinate at night, increased frequency of urination
• Sexual disorders, discomfort or enlargement of the breasts in men
• Pain, malaise
• Joint or muscle pain, back pain
• Weight gain or loss

Rare (may occur in less than 1 in 1,000 patients):

• Disorientation

Very rare (may occur in less than 1 in 10,000 patients):

• Decreased number of white blood cells, decreased number of platelets, which may lead to unusual bruising and easier bleeding
• Increased glucose levels in the blood (hyperglycemia)
• Nerve disorders, which may cause weakness, numbness, or tingling
• Gingival swelling
• Abdominal bloating (gastritis)
• Liver function disorders, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity in blood tests
• Increased muscle tone
• Vasculitis, often with skin rash
• Photosensitivity

Unknown (frequency cannot be estimated from the available data):

• tremor, stiffness, mask-like face, slow movements and dragging of the feet when walking, unsteady gait

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Camlocor

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. Do not store above 30°C. Store in the original packaging to protect from light and moisture. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Camlocor contains

• The active substances of Camlocor are candesartan cilexetil and amlodipine (in the form of besylate). Each tablet contains 8 mg of candesartan cilexetil and 5 mg of amlodipine (in the form of besylate). Each tablet contains 16 mg of candesartan cilexetil and 5 mg of amlodipine (in the form of besylate). Each tablet contains 16 mg of candesartan cilexetil and 10 mg of amlodipine (in the form of besylate).
• The other ingredients are: microcrystalline cellulose (type 102), maize starch, sodium carboxymethylcellulose (type A), magnesium stearate, colloidal anhydrous silica, lactose monohydrate, maize starch, hydroxypropylcellulose (type EF), macrogol 8000, calcium carmellose, yellow iron oxide (E 172) - only in Camlocor 8 mg + 5 mg and 16 mg + 10 mg tablets, and red iron oxide (E 172) - only in Camlocor 16 mg + 5 mg and 16 mg + 10 mg tablets. See section 2 "Camlocor contains lactose and sodium".

What Camlocor looks like and contents of the pack

Camlocor, 8 mg + 5 mg, tablets: round, biconvex, two-layer tablets. One side of the tablet is light yellow with possible lighter spots and engraved with the symbol 8-5 on one side, the other side of the tablet is white to almost white. Tablet dimensions: diameter 8 mm, thickness 3.7 - 4.7 mm. Camlocor, 16 mg + 5 mg, tablets: round, slightly biconvex, two-layer tablets. One side of the tablet is light pink with possible lighter and darker spots and engraved with the symbol 16-5 on one side, the other side of the tablet is white to almost white. Tablet dimensions: diameter 9 mm, thickness 4.0 - 5.0 mm. Camlocor, 16 mg + 10 mg: round, biconvex, two-layer tablets. One side of the tablet is light pink with possible lighter and darker spots and engraved with the symbol 16-10, the other side of the tablet is white to almost white. Tablet dimensions: diameter 8 mm, thickness 3.7 - 4.7 mm. Camlocor tablets are available in packs of 7, 10, 14, 28, 30, 50, 56, 60, 90, 98, 100, 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 90 x 1, 98 x 1, or 100 x 1 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia. For more information about this medicine, the patient should contact their local representative of the marketing authorization holder: KRKA Polska Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland, tel.: 22 57 37 500. Date of last revision of the leaflet: 10.05.2024